Kornimate/medical-research-clean huggingface dataset:
acute exposure of high altitude on cardiac output

Conditions: Pulmonary Hypertension

Summary: randomized crossover trial in patients with pulmonary hypertension (pah, cteph) to assess the acute response high altitude (säntis; 2500m above sea level) on non-invasive cardiac output assessments by finapres® nova technology at rest and under exercise

low altitude baseline measurements will be performed in zurich (460m asl) including echocardiography, right heart catheterization, 6mwt, pulmonary function test, clinical assessment and blood gas analysis. randomly assigned to the order of testing, the participants will be tested in low altitude (zurich, 470m) and at high altitude (2500m). during the exposure high altitude (2500m) and low altitude (zurich; 470m) up to 5 hours, the participants cardiac output non-invasively assessed will be measured repetitive during the whole intervention.

Eligibility criteria:
inclusion criteria: * informed consent * ph diagnosed according to internation guidelines: mpap ≥ 25 mmhg along with a pawp ≤15 mmhg during right heart catheterization at the time of initial diagnosis * ph class 1 (pah) or 4 (cteph) * stable condition, on the same medication for \> 4 weeks * patient live permanently at an altitude \< 1000m asl. exclusion criteria: * resting pao2 ≤7.3 kpa corresponding to the requirement of long-term oxygen therapy \> 16hour daily (nocturnal oxygen therapy alone is allowed) * severe daytime hypercapnia (pco2 \> 6.5 kpa) * susceptibility to high altitude related diseases (ams, hape, etc.) based on previous experienced discomfort at altitudes. * exposure to an altitude \>1500m for ≥3 nights during the last 4 weeks before the study participation * residence \> 1000m above sea level * inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, neurological or orthopedic problems with walking disability * women who are pregnant or breast feeding

Keywords: high altitude non-invasive cardiac output finapres
treating growing patients with mandibular prognathism and maxillary constriction

Conditions: Class III Malocclusion

Summary: this randomized controlled trial intends to test the efficacy of two treatment protocols in the correction of class iii malocclusion with maxillary constriction. we have to options, either to modify the growth using inter-maxillary traction based on an upper fixed appliance that is used in the same time for rapid maxillary expansion or to inhibit mandibular growth by a removable mandibular retractor (rmr) supplied with an expansion screw.


Eligibility criteria:
inclusion criteria: 1. growing male and female patients aged between 12 and 15 years 2. angle's class iii malocclusion 3. skeletal class iii relationship judged clinically and confirmed radiographically (-4 \< anb \< + 1) 4. an anterior crossbite involving two or more teeth or an edge-to-edge incisor relationship with or without an anterior shift of the lower jaw upon closure 5. normal inclination of the lower incisors or slightly proclined (i.e., the impa between 85° and 100° 6. maxillary constriction requiring expansion judged clinically and confirmed radiographically 7. permanent dentition 8. no previous orthodontic treatment exclusion criteria: 1. skeletal class iii malocclusion caused predominantly by maxillary deficiency (sna\<78° with a normal snb angle) 2. severe skeletal class iii presenting mainly due to mandibular protrusion (anb \< - 4° with no functional shift on closure) 3. contraindications for the use of the mini-screws, such as osteoporosis (addressed with cortisone and its derivatives) or those undergoing radiation treatment 4. a convergence between the mandibular canine root and the first premolar root ,which was assessed radiographically 5. facial asymmetry, characterized by a mandibular midline deviation exceeding 2 mm from the facial midline 6. mm angle \>35° or sn-mp angle \> 40° 7. the existence of cleft lip or craniofacial syndromes and/or palate abnormalities and 8. the existence of supernumerary teeth or missing ones except for the third molars.
evaluate pk and safety of proellex® in females with various stages of impaired renal function and healthy females

Conditions: Renal Impairment

Summary: pk and safety profile of proellex® in females with various stages of impaired renal function

the study will evaluate the pharmacokinetics and safety profile of proellex® in females with various stages of impaired renal function and in volunteers with normal renal function

Eligibility criteria:
inclusion criteria: * speak, read, and understand english or spanish and is willing and able to provide written informed consent on an irb-approved form prior to the initiation of any study procedures; * female, between the ages of 18 and 48 years with body mass index (bmi) between 18 and 39, inclusive, is preferred * subject must meet the criteria of mildly or moderately impaired renal function or have normal renal function * subject with renal impairment must have evidence of stable disease * if on medications for treatment of the complications of renal disease, and other concommitant chronic illnesses, subject must have been taking the medications at a stable dose for at least 10 days prior to the first proellex® dosing date and are then to be continued at the same dose for the duration of the study. * negative urine pregnancy test at screening visit * subject must agree to use a medically acceptable and effective non-hormonal double barrier method of birth control * healthy subject must have no significant abnormal findings at the screening physical examination * subject is willing to remain in the clinic for the screening visit (approximately 1 day for the first screening visit) and for the treatment visit (approximately 3 days) * additional inclusion criteria may apply exclusion criteria: * abnormal screening visit vital signs or clinical laboratory evaluation considered clinically significant * subject with clinically significant abnormal liver function * pregnant or lactating females, or women who are attempting or expecting to become pregnant at any time during the study or one month after the study * an acute illness within five (5) days of study medication administration * subject with diagnosed or suspected carcinoma of the breast, reproductive organs or any other organ system * additional exclusion criteria may apply

Keywords: renal impairment
clinical outcomes of indocyanine green tracer using in laparoscopic gastrectomy with extended lymphadenectomy beyond d2 for locally advanced gastric cancer (fuges-30)

Conditions: Gastric Cancer; Surgery

Summary: taking patients with locally advanced gastric adenocarcinoma (ct2-4a, n-/+, m0) as the research subjects, to evaluate whether the clinical efficacy of laparoscopic beyond d2 regional lymph node dissection for gastric cancer with indocyanine green tracer is better or not.


Eligibility criteria:
inclusion criteria: age from 18 to 75 years primary gastric adenocarcinoma (papillary, tubular, mucinous, signet ring cell, or poorly differentiated) confirmed pathologically by endoscopic biopsy ct2-4a, n-/+, m0 at preoperative evaluation according to the ajcc cancer staging manual, 8th edition no distant metastasis, no direct invasion of pancreas, spleen or other adjacent organs in the preoperative examinations performance status of 0 or 1 on the ecog (eastern cooperative oncology group) scale asa (american society of anesthesiology) class i to iii written informed consent exclusion criteria: women during pregnancy or breast-feeding severe mental disorder history of previous upper abdominal surgery (except for laparoscopic cholecystectomy) history of previous gastric surgery (including esd/emr for gastric cancer) enlarged or bulky regional lymph node (diameter over 3cm) supported by preoperative imaging including enlarged or bulky lymph nodes in d3 region. other malignant disease within the past 5 years history of unstable angina or myocardial infarction within past six months history of cerebrovascular accident within past six months history of continuous systematic administration of corticosteroids within one month requirement for simultaneous surgery for other disease emergency surgery due to complication (bleeding, obstruction or perforation) caused by gastric cancer fev1 (forced expiratory volume in one second)\<50% of predicted values diffuse invasive gastric cancer tumors preoperatively confirmed to involve the squamocolumnar junction or duodenum history of an iodine allergy patients who declined laparoscopic surgery

Keywords: gastric cancer laparoscopic gastrectomy indocyanine green tracer
varenicline for co-occurring cannabis and tobacco use

Conditions: Cannabis Dependence; Tobacco Dependence

Summary: pilot, eight week, open-label, within-subject cross over trial of four weeks of standard clinical care (scc) in an outpatient substance use disorder treatment program and four weeks of scc and varenicline among current and former tobacco smokers with frequent cannabis use.

treating co-occurring cannabis and tobacco use disorders might reduce the health burdens associated with both substances. however, few studies have evaluated pharmacological interventions, in combination with behavioral treatment, to address co-occurring cannabis and tobacco use; these are limited by high participant attrition, poor adherence to interventions, and lack of control. pilot, eight week, open-label, within-subject cross over trial of four weeks of standard clinical care (scc) in an outpatient substance use disorder treatment program and four weeks of scc and varenicline among current and former tobacco smokers with frequent cannabis use. participants were recruited from an urban, outpatient substance use disorder treatment program that offers both intensive behavioral counseling and medications for opioid use disorder (moud). participants were randomized to receive either scc or scc and varenicline first and then were crossed over to receive the opposite intervention. the study consisted of two 4-week treatment periods with no washout period. outcomes are reported in pooled analyses of all participants in each treatment phase.

Eligibility criteria:
inclusion criteria: * able to speak english * uses cannabis at least 5 days in the past 7 days * current or former tobacco smoker * has not taken varenicline in the past 30 days * not pregnant, trying to conceive or breastfeeding * able to provide informed consent * test positive for cannabinoids by urine toxicology exclusion criteria: * unstable medical or psychiatric illness * opioid use disorder was initially exclusionary but eligibility criteria were revised after 32 individuals were screened to facilitate recruitment.
evaluation of the interest of a specialist in dermatology for dermatopediatric consultations

Conditions: Dermatologic Disease; Pediatric ALL; Collaboration

Summary: dermatologic diseases, of very different etiology and variable severity, represent a major motivation for consultation (in private consultations and in emergency departments), thus leading pediatricians to frequently turn to dermatologic advice. the principal aim is to estimate the degree of concordance of the main diagnosis between a pediatrician and a pediatric dermatologist. the secondary aims is to estimate the degree of concordance of the treatment, advices and follow-up.


Eligibility criteria:
inclusion criteria: * under 18 years old * consultating for dermatologic problem in emergency department (1 department) or private pediatric center (1 center) * signed consent * consécutives consultations exclusion criteria: * no consent
effects of intravenous injection of erythropoietin on hepcidin pharmacokinetics in healthy volunteers

Conditions: Iron Metabolism Disorders

Summary: the aim of this study is to measure the variations of serum and urinary hepcidin levels following a single intravenous injection of erythropoietin in healthy volunteers. hepcidin is a major regulator of iron homeostasis. it acts by binding on ferroportin, and limits cellular efflux of iron through enterocytes and macrophages. anemia and hypoxia are known to modulate hepcidin synthesis. in these situations, erythropoietin synthesis is increased, so it can be postulated that erythropoietin could modulate hepcidin synthesis.


Eligibility criteria:
inclusion criteria: * healthy volunteers * male aged 18 - 30 * normal routine laboratory values * normal ecg * normal iron status exclusion criteria: * c282y mutation of the hfe gene * alcohol or tobacco consumption
investigating the effectiveness of vimida

Conditions: Long COVID; Post COVID-19 Condition

Summary: this randomized controlled trial (rct) with 160 patients suffering from fatigue after covid-19 infection aims to investigate the effectiveness of the unguided digital therapeutic vimida for reducing post-covid-19 fatigue. inclusion criteria are: male, female or non-binary, age ≥18 years, diagnosis of post-covid-19 fatigue, ≥3 months since the last infection with covid-19, fatigue severity score (cut-off) of ≥ 16 on the chalder fatigue scale (cfq-11), consent to participation, and sufficient german language skills. exclusion criteria are a known psychiatric or somatic condition that can explain the fatigue and current participation in a multidisciplinary rehabilitation program aimed to ameliorate the consequences of covid-19. patients will be randomized and allocated to either an intervention group, in which they will receive access to vimida in addition to treatment as usual (tau; n=80), or to a control group, in which they will receive access to tau only (n=80). the primary endpoint will be fatigue symptoms with three months post-allocation (t1) being the primary time point for assessment of effectiveness. six months post-allocation (t2) will be used as follow-up assessment of endpoints. secondary endpoints will be depressive symptoms, mental health-related quality of life, work/social functioning, somatic symptoms, and anxiety symptoms.


Eligibility criteria:
inclusion criteria: * male, female or non-binary * age ≥ 18 * diagnosis of post-covid-19 fatigue (icd-10 u08.9, or u09.9 in conjunction with g93.3), secured via a telemedical visit * ≥ 3 months since covid-19 infection that preceded fatigue symptoms * elevated levels of fatigue: cut-off of ≥ 16 on the cfq-11 * consent to participation * sufficient knowledge of the german language exclusion criteria: * known somatic or psychiatric condition that can explain the fatigue (e.g., cancer, multiple sclerosis, severe depression) * current participation in a multidisciplinary rehabilitation program aimed at ameliorating the consequences of covid-19
exposure-based treatment for avoidant back pain patients

Conditions: Low Back Pain

Summary: chronic low back pain often results in psychosocial and physical disability. a subgroup of these patients shows fear of (re)injury and avoidance behaviour leading to higher disability. the purpose of this study is to determine whether exposure in vivo is more effective in the treatment of fear avoidant chronic back pain patients than psychological treatment as usual (cognitive behavioural psychotherapy).


Eligibility criteria:
inclusion criteria: * having at least 3 months back pain * sufficient level on fear avoidance scores (tsk, phoda) * being german-speaking * agreeing to participate, verified by completion of informed consent exclusion criteria: * red flags * pregnancy * illiteracy * psychoses * alcohol addiction * surgeries during the last 6 months or planed surgeries * specific medical disorders or cardiovascular diseases preventing participation in physical exercise * participating in another psychotherapy

Keywords: chronic low back pain cognitive behavioural therapy exposure fear avoidance cognitive behavioural therapy in chronic low back pain exposure in vivo in chronic low back pain
effects of horticultural therapy on elderly at risk of cognitive decline

Conditions: Horticultural Therapy; Dementia

Summary: the objective of this study is to determine whether horticultural therapy would improve the psychological well-being older adults who are at risk of memory (cognitive) decline. 100 elderly subjects who are at risk of cognitive decline will be randomized into the active horticultural therapy or to the waitlist control group. sessions will be conducted weekly for 9 months, and participants will be assessed at 3 time-points: at the start of the study, at 3 months and at 9 months. it is hypothesized that participants who undergo horticultural therapy will perform better on neuropsychological tests when compared to control, and that they will have improved psychological well-being and functional outcomes.

study participants comprise of community-dwelling elderly who are at risk of developing dementia, and will be selected from consenting participants from an existing community cognitive screening program. this is an intervention study where 100 subjects will be randomized into an active horticultural therapy group, or a waitlist control group. baseline demographic data will be collected at the start of the study. assessments will be done at the start, at 3 months and at 6 months, which will include neuropsychological tests of cognitive functioning, psychological tests for depression and anxiety, assessment of psychosocial well-being, and tests of functional status. the horticultural therapy intervention will be delivered by trained facilitators at the therapeutic garden at hort park, and consists of 1 hour sessions weekly for 9 months. the horticultural therapy program is designed to stimulate the senses through interaction with the tasks and the environment, promote social interaction and also to promote a sense of self-worth through completion of projects. it encompasses a range of activities including general gardening and also project-based craft activities. the control group will be placed on a waiting list and only be contacted for assessments. they will receive intervention after the active treatment group at a later date.

Eligibility criteria:
inclusion criteria: 1. community-living elderly aged 60 years and above, and 2. 1. mild cognitive impairment based on clinical history and neuropsychological test scores (z score \ -1.5), or 2. subjective memory impairment based on self-report, or (c) 2 or more risk factors for dementia such as family history, cerebrovascular disease, and cardiovascular risk factors exclusion criteria: 1. existing diagnosis of dementia, or 2. comorbid major mental illness (such as major depressive disorder and psychosis), or 3. severe or unstable life-limiting medical illness, or 4. severe physical impairment precluding participation in horticultural therapy

Keywords: horticultural therapy dementia randomized controlled trial elderly prevention
a treatment legacy effect of metformin in obese women with pcos

Conditions: PCOS

Summary: metformin has multiple health promoting effects and it may serve as a preventive measure for individuals who are at high risk for metabolic complications. according to the latest international guidelines it should be considered as an adjunct therapy to lifestyle intervention in all overweight/obese women with pcos, independently of their glucose homeostasis and menstrual regularity. however, there is no clear answer for how long metformin should be prescribed in this subset of women with pcos and for how long the beneficial impact would sustain after treatment cessation. the investigators compared the consequences of metformin withdrawal after long-term therapy as opposed to the consequences of metformin suspension after short term therapy in overweight/obese women with pcos that had previously responded to metformin by means of moderate weight loss, improved menstrual frequency and sustained normal glucose homeostasis.


Eligibility criteria:
inclusion criteria: * pcos defined by the national institute of child health and human development (nichd) criteria * obesity with body mass index ≥ 30 kg/m2 * normal glucose homeostasis at metformin treatment exclusion criteria: * known type 1 or type 2 diabetes mellitus * heart failure * renal insufficiency with serum creatinine more than 125 umol/l * arterial hypertension * pregnancy * bmi below 25 kg/m2

Keywords: pcos obesity metformin
enuresis alarm - is a manual trigger system beneficial?

Conditions: Enuresis, Nocturnal

Summary: the purpose of this study is to evaluate whether the bedwetting alarm trigger activated by parents to wake their child, in addition to the moisture alarm, will improve treatment success compared to the moisture alarm alone.

nocturnal enuresis is a common issue in children, and use of bedwetting alarms has shown the best long-term success. however, use of alarms is very time-intensive, often taking months before yielding results. researchers in the division of pediatric urology are initiating a randomized controlled study comparing a standard bedwetting alarm with a newly developed technology, with the hope that the new alarm will result in better, more rapid, and easier treatment for bedwetting. children between the ages of 5 to 15 years old who have issues with bedwetting after successful toilet training may qualify for the study. participants must first be evaluated by a pediatric urology specialist.

Eligibility criteria:
inclusion criteria: * children ages 5-15 years * diagnosis of primary monosymptomatic nocturnal enuresis * \>2 wet nights per week * score of 7 or below on questions 1-6 and 9-13 on vancouver dysfunctional elimination questionnaire * patients/parents compliance in recording data \> 50% of nights exclusion criteria: * known comorbid conditions: daytime incontinence, anatomic abnormalities (hydronephrosis, vur), recurrent urinary tract infection, dysuria, neurogenic bladder, developmental delay, encopresis, diabetes insipidus, previous history of urologic surgery * concomitant ddavp use, anticholinergic use, b3 agonist use
pharmacokinetic study of testosterone enanthate

Conditions: Hypogonadism

Summary: relative bioavailability and safety comparison of 3 formulations of testosterone enanthate.

standard pharmacokinetic (pk) analyses of data for serum testosterone were done. cmax, area under curve (auc), and cavg were used for the comparison of relative bioavailability of the treatments and reference arm. safety comparisons were based upon the occurrence, severity and rate of treatment emergent adverse events.

Eligibility criteria:
inclusion criteria: * adult males aged 18 to 75 with a documented diagnosis of hypogonadism exclusion criteria: * normal testosterone levels * subjects with any clinically significant medical condition which, in the opinion of the investigator, would make the subject an unsuitable candidate for enrollment in the study

Keywords: hypogonadism testosterone enanthate